Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS
FDA 510(k) K033112 · Hand Biomechanics Lab, Inc.
510(k) numberK033112
Submission
- Device name
- Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS
- Applicant
- Hand Biomechanics Lab, Inc.
Sacramento, CA, US - Received
- September 30, 2003
- Decision date
- November 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | 10/15/2025SE |
| K222490 | HBL Blade AssemblyHRX · Traditional | 11/14/2022SE |
| K181192 | PIP FixJEC · Traditional | 10/22/2018SE |
| K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileJEC · Traditional | 01/09/2008SE |
| K030519 | Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNSJEC · Traditional | 06/10/2003SE |
| K992970 | Digit WidgetJDW · Traditional | 11/08/1999SE |
| K984442 | Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147JEC · Traditional | 02/12/1999SE |
| K942906 | Agee-Wristjack Pre-Drill KitHTW · Traditional | 12/22/1994SE |
Questions and answers
When was Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS cleared by the FDA?
Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS (K033112) received a 510(k) decision of Substantially Equivalent on November 5, 2003, 36 days after the submission was received.
What is the product code of K033112?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.